FDA Review Panel · NE

FDA 510(k) Neurology Devices

FDA 510(k) Neurology Devices - Regulatory Overview

FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.

Common categories include:

  • EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
  • Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
  • Surgical navigation systems - image-guided neurosurgery platforms
  • Intracranial pressure monitors - ICP sensors and drainage systems
  • Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery

6291
Total
6236
Cleared
153d
Avg (2y)
1976
Since
4728 Neurology devices
2576–2600 of 4728
Cleared Sep 07, 2007
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · Integra LifeSciences Corporation
HBL · Holder, Head, Neurosurgical (skull Clamp) · 30d
Cleared Sep 05, 2007
ALPHAONE BIOFEEDBACK SYSTEM
K071661 · Telediagnostic Systems, Inc.
HCC · Device, Biofeedback · 78d
Cleared Sep 05, 2007
COMFY SERIES: EV-804, EV-805 & EV-806
K071951 · Everyway Medical Instruments Co.,Ltd
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 51d
Cleared Aug 24, 2007
LORENZ BIOTECH APTIVA, VERSION 2.13
K061828 · Lorenz Biotech S.P.A.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 422d
Cleared Aug 23, 2007
SPINEASSIST SYSTEM
K063607 · Mazor Surgical Technologies , Ltd.
HAW · Neurological Stereotaxic Instrument · 262d
Cleared Aug 23, 2007
DURAGEN XS DURAL REGENERATION MATRIX
K072207 · Integra Lifesciences Corp.
GXQ · Dura Substitute · 15d
Cleared Aug 23, 2007
THERMOGARD XP THERMAL REGULATION SYSTEM
K072234 · Alsius Corp.
NCX · System, Hypothermia, Intravenous, Cooling · 13d
Cleared Aug 22, 2007
MODIFIED MERCI RETRIEVER, MODEL 90060
K071172 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 117d
Cleared Aug 21, 2007
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
K063729 · Technomed Europe
GXZ · Electrode, Needle · 249d
Cleared Aug 16, 2007
INSIGHT DISCOVERY
K063447 · Fasstech
IKN · Electromyograph, Diagnostic · 274d
Cleared Aug 16, 2007
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
K063836 · Medtronic Neurosurgery
JXG · Shunt, Central Nervous System And Components · 233d
Cleared Aug 15, 2007
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
K071138 · Prosurg, Inc.
GXR · Cover, Burr Hole · 152d
Cleared Aug 06, 2007
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505 · Integra LifeSciences Corporation
GWM · Device, Monitoring, Intracranial Pressure · 66d
Cleared Aug 03, 2007
NEUROPORT ELECTRODE
K070272 · Cyberkinetics Neurotechnology Systems, Inc.
GZL · Electrode, Depth · 186d
Cleared Aug 02, 2007
INSTRUMED RETRACTORS
K071771 · Instrumed International, Inc.
GZT · Retractor, Self-retaining, For Neurosurgery · 34d
Cleared Jul 31, 2007
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
K070731 · Plus Orthopedics AG
HAW · Neurological Stereotaxic Instrument · 138d
Cleared Jul 30, 2007
MAXINSIGHT
K070358 · Eemagine Medical Imaging Solutions GmbH
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 173d
Cleared Jul 30, 2007
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186 · Ambu A/S
IKT · Electrode, Needle, Diagnostic Electromyograph · 91d
Cleared Jul 30, 2007
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
K071791 · Codman & Shurtleff, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 28d
Cleared Jul 27, 2007
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
K071821 · Tonica Elektronik A/S
GWF · Stimulator, Electrical, Evoked Response · 24d
Cleared Jul 26, 2007
PSI BANDS
K070766 · Psi Health Solutions, Inc.
MVV · Device, Acupressure · 128d
Cleared Jul 26, 2007
ANEUROPLASTIC, MODEL 43-1290
K071776 · Codman & Shurtleff, Inc.
JXH · Methyl Methacrylate For Aneurysmorrhaphy · 27d
Cleared Jul 25, 2007
MICROTARGETING GUIDELINE 4000
K071364 · FHC, Inc.
GZL · Electrode, Depth · 70d
Cleared Jul 20, 2007
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · Smith & Nephew, Inc.
GXI · Probe, Radiofrequency Lesion · 72d
Cleared Jul 20, 2007
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
K071714 · Orthosoft, Inc.
HAW · Neurological Stereotaxic Instrument · 28d

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All categories 4728 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 278 JXG Shunt, Central Nervous System And Components 222 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 141 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 100 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67